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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
SIDS INITIAL ASSESSMENT PROFILE for Phosphoric acid
Author:
SIDS
Year:
2009
Bibliographic source:
https://hpvchemicals.oecd.org/ui/handler.axd?id=0c142f1e-37eb-404d-90ac-be4a9f440ebd
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Principles of method if other than guideline:
The reproductive toxicity of phosphoric acid has been investigated in a reproductive and developmental toxicity screening test in rats [OECD TG 422]. In this study, phosphoric acid was administered via gavage to 13 of animals/sex/dose, concentration at 0, 125, 250 and 500 mg/kg bw/day, for 2 weeks. Based on results of reproductive and development toxicity, no treatment-related effects were observed. At 500 mg/kg bw/day, 2/13 adult females died, indicating parental toxicity at this dose. No effects of test substance were observed on mating, conception, parturition and external of neonates, neonate body weights, and survival rate. Therefore, NOAEL for reproductive and development toxicity was estimated to be 500 mg/kg bw/day, the highest dose tested.
GLP compliance:
not specified
Remarks:
Secondary source
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Orthophosphoric acid
EC Number:
231-633-2
EC Name:
Orthophosphoric acid
Cas Number:
7664-38-2
Molecular formula:
H3O4P
IUPAC Name:
phosphoric acid

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
2 weeks.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
125 mg/kg bw/day
Dose / conc.:
250 mg/kg bw/day
Dose / conc.:
500 mg/kg bw/day
No. of animals per sex per dose:
13 animals/sex/dose

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Effect level:
500 mg/kg bw/day
Remarks on result:
other: At 500 mg/kg bw/day, 2/13 adult females died, indicating parental toxicity at this dose.

Target system / organ toxicity (P0)

Critical effects observed:
yes
Lowest effective dose / conc.:
500 mg/kg bw/day (nominal)
System:
other: Parental toxicity
Organ:
not specified
Treatment related:
yes
Dose response relationship:
yes

Results: F1 generation

Details on results (F1)

No effects of test substance were observed on mating, conception, parturition and external of neonates, neonate body weights, and survival rate. Therefore, NOAEL for reproductive and development toxicity was estimated to be 500 mg/kg bw/day, the highest dose tested.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Reproductive and development toxicity
Remarks on result:
other: Therefore, NOAEL for reproductive and development toxicity was estimated to be 500 mg/kg bw/day, the highest dose tested.

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Any other information on results incl. tables

Based on results of reproductive and development toxicity, no treatment-related effects were observed.

Applicant's summary and conclusion

Executive summary:

The reproductive toxicity of phosphoric acid has been investigated in a reproductive and developmental toxicity screening test in rats [OECD TG 422]. In this study, phosphoric acid was administered via gavage to 13 of animals/sex/dose, concentration at 0, 125, 250 and 500 mg/kg bw/day, for 2 weeks. Based on results of reproductive and development toxicity, no treatment-related effects were observed. At 500 mg/kg bw/day, 2/13 adult females died, indicating parental toxicity at this dose. No effects of test substance were observed on mating, conception, parturition and external of neonates, neonate body weights, and survival rate. Therefore, NOAEL for reproductive and development toxicity was estimated to be 500 mg/kg bw/day, the highest dose tested.